Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The focus of this study is to examine changes in pain scores, strength, and range of motion over time following an ultrasonic tenotomy on a partial tear (<50%) of the supraspinatus tendon of the rotator cuff.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repair a partially torn rotator cuff | Other | Subjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic tenotomy | Procedure | Ultrasonic procedure as part of standard of care, as clinically indicated, to stimulate healing of the partial tear. The procedure uses ultrasound guidance that allows a needlelike device to gradually break up and remove tendinopathic tendon tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain | Measured using a visual analog scale (VAS), used to measure subjective pain, rated from 0 (no pain) to 100 (most severe pain) at rest and during activity (previously painful activities) | Baseline, 2, 6, 12 and 24-weeks post-procedure |
| Change in shoulder active range of motion | Measured using a goniometer reported in degrees | Baseline, 2, 6, 12 and 24-weeks post-procedure |
| Change in shoulder strength | Assessed using a hand-held dynamometer (HHD) placed distally on the forearm, just proximal to the wrist joint along the distal radius and ulna with instruction to push into the HHD with maximum force production for approximately 5 seconds. | Baseline, 2, 6, 12 and 24-weeks post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Measured using the SF-36 Quality of Life questionnaire which is a 36-item self-reported health survey that measures health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability. | Baseline, 2, 6, 12 and 24-weeks post-procedure |
Not provided
Inclusion Criteria:
- Evidence of partial tear (< 50%) of the supraspinatus tendon on MRI.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacob Erickson, DO | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System - Onalaska | Recruiting | Onalaska | Wisconsin | 54650 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|